Generic Avodart Launched
October 12, 2015 – Teva launched its AB-rated generic to GlaxoSmithKline’s Avodart (dutasteride) 0.5mg capsules. Avodart is an alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the potential need for BPH-related surgery. BPH is a common problem among older men with incidence increases from about 8% in men aged 31 to 40 years to over 80% in men older than 80 years of age. Avodart is available in 0.5mg capsules.
Teva’s generic was launched based on terms of a settlement agreement; however, the FDA can approve additional generics from several other manufacturers after Avodart’s patent expires on November 10, 2015. Providing treatment for similar indications is Proscar (finasteride tablets) which is a 5 alpha-reductase inhibitor manufactured by Merck. Generics to Proscar have been on the market since June 2006.
Annual U.S. sales 15 for Avidart was $467 million for the most recent 12 months ending in July, 2015 according to IMS health.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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